Johns Hopkins enters suit over lab animal regulations

The Johns Hopkins University, saying that the future of health research is at stake, asked a federal court today for permission to intervene in a dispute in which animal rights activists are seeking to make biomedical experiments with mice and rats virtually impossible to conduct.

"The animal rights groups' true motive in this case is to halt all animal-based medical research in the United States, with total disregard to the human consequences," said Estelle Fishbein, vice president and general counsel of the university.

The university asked to be made a party to a lawsuit filed by animal rights groups against the Department of Agriculture. The groups are seeking to force the department to apply to mice, rats and birds the extensive record-keeping and other regulations that now apply to far smaller numbers of larger experimental animals such as primates and dogs.

Mice and rats have long been critical to biomedical research because their short life cycles make research go faster and because they are, compared with other animals, inexpensive to use. With the explosive advance in knowledge of genetics in recent years, mice have become even more important because of scientists' ability to breed them in ways that demonstrate the role of specific genes.

The Public Health Service, a part of the Department of Health and Human Services, already regulates the use of experimental mice, rats and birds. Those animals now are exempt from the Agriculture Department regulations, which are designed for application to smaller populations of larger animals. The USDA regulations require, among other things, keeping extensive records on each individual animal.

The National Association for Biomedical Research estimates that 23 million mice
and rats were used in 1999 in research nationwide and expects that number to grow by at least 50 percent in three years. At Johns Hopkins, the recipient of more federal research dollars than any other university, 468 faculty members are now using about 42,000 mice, 3,000 rats and 300 birds in their laboratories. Based on expected growth in research, the university is investing $30 million in a facility to breed and maintain 140,000 mice and rats.

"Keeping such individualized written records on the many thousands of mice, rats and birds at Hopkins to comply with USDA regulations designed for other species would be virtually impractical, and probably impossible; would greatly increase the financial and personnel burden on Hopkins' research; and [would] undermine the cost-based reasons for using these animals in research," Hopkins said in a filing in U.S. District Court in Washington.

Plaintiffs in the suit that the university seeks to enter have claimed that the USDA's exemption of mice, rats and birds from its regulations is illegal. Johns Hopkins, if allowed to intervene, will argue that the exemption is expressly legal under the language of the Animal Welfare Act and consistent with the intent of Congress.

"The current PHS guidelines applicable to birds, rats and mice are reasonable and adequate to ensure the humane treatment of these species, so there is no compelling need to add yet another layer of regulatory effort to this subject," the university's filing said.

At a minimum, a victory by the plaintiffs would greatly slow the pace of medical advances and make research far more expensive, the university said. It likely would result in research being shifted to areas of the world with little or no regulatory oversight, the university added.

The university said it is necessary to intervene because the federal government may no longer be representing the interests of researchers and patients in the controversy. The government has told the court it is holding settlement negotiations with the plaintiffs.

"A settlement reached without the participation of representatives of the nation's research community ... is likely to include capitulation in full or in part to the plaintiffs'
demands," the university said.

"Hopkins was dismayed when it learned that the USDA is blocking any attempt by the research community to participate in negotiations that may directly affect U.S. leadership in biomedical research," Fishbein said. "Johns Hopkins will not sit idly by and watch this happen."

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Note: The case is Alternatives Research and Development Foundation et al. v. Daniel Glickman, Secretary of Agriculture, et al, Civil Case No. 99-581 (ESH) in U.S. District Court in Washington, D.C. U.S. District Judge Ellen Segal Huvelle is hearing the case.

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